The Effectiveness of Warm Hand Bath in Improving Anxiety

NCT06041672 | Unknown

• 1 other identifier: CGH-P112023
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients undergoing surgery often experience anxiety before the procedure. The aim of this study is to investigate the effectiveness of warm water baths in reducing preoperative anxiety levels in middle-aged and elderly patients undergoing lower limb orthopedic surgery. This study utilizes a randomized controlled trial design and focuses on middle-aged and elderly patients undergoing lower limb orthopedic surgery in the orthopedic ward of a medical center in northern Taiwan. The patients are divided into an experimental group and a control group using block randomization. Patients in the experimental group receive a 10-minute warm water bath at 40°C on the evening before surgery as an intervention, while the control group receives standard care. Data are collected from both groups before and after the intervention, including personal information, the State-Trait Anxiety Inventory, Visual Analog Scale for pain assessment, and Visual Analog Scale for relaxation, as well as vital sign measurements. Statistical analysis of the data is conducted using SPSS version 18.0 software, employing mean values, standard deviations, percentages, independent t-tests, chi-square tests, paired-sample t-tests, and generalized estimating equations for data analysis.

Conditions

Preoperative Anxiety

Keywords

lower limb bone surgery; warm water hand bath; preoperative anxiety

Outcome Measures

Primary Outcomes (2)

• State-Trait Anxiety Inventory,A-State,STAI-S

  The questionnaire consists of 20 items, and research subjects are asked to select the response that best represents their current feelings of anxiety for each item. It is scored on a four-point Likert scale, with responses ranging from "Not at all" (scored as 1 point), "Somewhat" (scored as 2 points), "Moderately so" (scored as 3 points), to "Very much so" (scored as 4 points). Among the 20 items, 10 are reverse-scored (items 3, 4, 6, 7, 9, 12, 13, 14, 17, and 18), meaning that the scoring is reversed for these items. The total score ranges from 20 to 80 points, with higher scores indicating a higher level of anxiety.

  Baseline, before the intervention(T0)

• State-Trait Anxiety Inventory,A-State,STAI-S

  The questionnaire consists of 20 items, and research subjects are asked to select the response that best represents their current feelings of anxiety for each item. It is scored on a four-point Likert scale, with responses ranging from "Not at all" (scored as 1 point), "Somewhat" (scored as 2 points), "Moderately so" (scored as 3 points), to "Very much so" (scored as 4 points). Among the 20 items, 10 are reverse-scored (items 3, 4, 6, 7, 9, 12, 13, 14, 17, and 18), meaning that the scoring is reversed for these items. The total score ranges from 20 to 80 points, with higher scores indicating a higher level of anxiety.

  Immediately following after the intervention(T1)

Secondary Outcomes (4)

• The pain(Visual Analogue Scale, VAS)

  Baseline, before the intervention(T0)

• The pain(Visual Analogue Scale, VAS)

  Immediately following after the intervention(T1)

• The Relaxation (Visual Analogue Scale,VAS)

  Baseline, before the intervention(T0)

• The Relaxation (Visual Analogue Scale,VAS)

  Immediately following after the intervention(T1)

Study Arms (2)

Warm Water Hand Baths

EXPERIMENTAL

Patients in the experimental group have their hand immersed in warm water (40°C) for ten minutes.

Behavioral: Warm Water Hand Baths

Routine care

NO INTERVENTION

Including preoperative instructions, postoperative care, and monitoring of vital signs.

Interventions

Warm Water Hand Baths BEHAVIORAL

1. Patients in the experimental group receive warm water hand baths as an intervention on the evening before surgery. 2. The intervention is carried out in the patient's room, room temperature was adjusted to 26°C and the timing is determined based on the patient's preference. 3. The study utilizes a foldable water bucket with temperature maintenance capability.Patients in the experimental group have their hand immersed in warm water (40°C) for ten minutes in a comfortable lying position.

Warm Water Hand Baths

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age must be forty-five years or older.
• Individuals diagnosed by a physician with lower limb bone-related conditions and planning to undergo orthopedic surgery.
• Must maintain clear consciousness and be able to communicate verbally.
• Patients with heart disease or diabetes must seek the opinion of the attending physicians (Dr. Liu Zhe-wei and Dr. Chen Yi-zhi) before undergoing this intervention.
• The study encompasses the following lower limb orthopedic surgeries:
• Total joint replacement surgery, including knee and hip joint replacements. Revision surgery for joint replacements. Joint osteotomy correction surgery. Arthroscopic joint surgery. Open reduction and internal fixation surgery. Other surgeries related to lower limb musculoskeletal conditions.

You may not qualify if:

• Patients with hand or wrist fractures.
• Individuals with peripheral circulation abnormalities.
• Patients with autonomic nervous system disorders who are taking anxiety-related medications.
• Pregnant women.
• Individuals with wounds, infections, swelling, or injuries on the skin of both palms, preventing immersion in water.
• Those suffering from other major illnesses or scheduled for two or more surgeries.
• Patients requiring physiological monitoring.
• Individuals needing a catheter placed below the wrist.

Sponsors & Collaborators

• Cathay General Hospital: lead

Related Publications (14)

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• 譚博謙. (2018). 探討足浴對女大學生焦慮及生理參數之作用. 南華大學自然生物科技學系自然療癒碩士班碩士論文，嘉義縣. 取自 https://hdl.handle.net/11296/gnsfhc

  RESULT

Study Officials

• Yeu-Hui Chuang

  Taipei Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pei-Jung Wu

CONTACT

+886930220725; patty781027@gmail.com

Yeu-Hui Chuang

CONTACT

0227361661; yeuhui@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 18, 2023
• Study Start: December 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: December 11, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share